IP Library › Patent Application 15490883
Patent Application
App. No. 15/490,883

Fixed Dose Combination for Pain Relief Without Edema

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Quick Facts
Patent No.
US None
App. No.
15/490,883
Abstract

The invention provides compositions and methods for individualized therapy of arthritic pain without causing edema, using a non-steroidal anti-inflammatory drugs (COX-2 inhibitor) in combination with a diuretic drug. The NSAID is preferably celecoxib and the diuretic is preferably hydrochlorothiazide in a single dose

Claims (22)

1 . A composition for treating pain in a mammal, the composition comprising celecoxib and hydrochlorothiazide, wherein

(a) the celecoxib and the hydrochlorothiazide are in a single dosage unit;

(b) the celecoxib and the hydrochlorothiazide are each at a fixed dosage; where the HCTZ and the celecoxib are physically separated;

(c) the celecoxib is mixed with a disintegrant to counteract the dissolution suppression in the Fixed Dose Combination (FDC); and

(d) a dissolution profile for each of celecoxib and hydrochlorothiazide in the single dosage unit is equivalent to a dissolution profile of celecoxib and a dissolution profile hydrochlorothiazide if administered in separate dosage units, such that the f2 score based on this comparison is 50 to 100.

2 . The composition of claim 1 , wherein the single dosage unit has separate compartments for the celecoxib and the hydrochlorothiazide.

3 . The composition of claim 1 , wherein the pain is arthritic pain.

4 . The composition of claim 1 , wherein the arthritic pain is osteoarthritic.

5 . The composition of claim 1 , wherein the composition is in the form of a pill in a pill, a capsule in a capsule, a tablet in powder in a capsule, a mini-tablet in powder in a capsule, or a bilayer tablet.

6 . The composition of claim 1 , wherein the dose of celecoxib is 50 to 400 mg.

7 . The composition of claim 1 , where the dose of hydrochlorothiazide is 5 to 100 mg.

8 . The composition of claim 1 , wherein the dose of celecoxib is 100 mg and the dose of hydrochlorothiazide is 12.5 mg.

9 . The composition of claim 1 , wherein the dose of celecoxib is 200 mg and the dose of hydrochlorothiazide is 12.5 mg.

10 . The composition of claim 1 , wherein the dose of celecoxib is 100 mg and the dose of hydrochlorothiazide is 25 mg.

11 . The composition of claim 1 , wherein the dose of celecoxib is 200 mg and the dose of hydrochlorothiazide is 25 mg.

12 . The composition of claim 1 , wherein the dose of celecoxib is 400 mg and the dose of hydrochlorothiazide is 150 mg.

13 . The composition of claim 1 , wherein the dose of celecoxib is 300 mg and the dose of hydrochlorothiazide is 100 mg.

14 . The composition of claim 1 , wherein the disintegrant is selected from the group consisting of L-HPC, povidone, crospovidone, and carboxymethylcellulose calcium.

15 . The composition of claim 1 , wherein the disintegrant is L-HPC.

16 . A method for the treatment of pain with a reduction in the incidence of edema, comprising the administration of the composition of claim 1 to a mammal.

17 . The method of claim 16 , where in the pain is arthritic pain.

18 . The method of claim 17 , wherein the arthritic pain is osteoarthritic pain.